Specialist, Quality Systems & Compliance

Job Description

The Specialist, Quality Systems & Compliance in Device Regulatory & Quality, will be responsible for supporting MDCP Complaints team and other DQ&R Systems tasks and priorities as needed. This position will interact with cross-functional teams and sites. Activities will include review of documentation to ensure compliance with applicable Combination Product or Medical Device Regulations and internal of our company's requirements. In addition, the Specialist is responsible for execution of MDCP projects and support of the device data domain.

Primary activities include but are not limited to:

• Review reportable external customer complaints, upon intake, for appropriateness for health authority submission

• Document review/approval in complaint database

• Collaborate with the Site Complaint Investigating Unit and Device -Technical Operations (TO) to ensure the device and device components are adequately considered as part of the root cause analysis and to ensure the design of the device and device components are adequately considered when manufacturing or packaging root causes are not identified.

• Collaborate with Site Complaint Investigating Unit and Device to ensure robust corrective and/or preventive actions are put in place to address external customer complaints

• Review the Device Risk Management Files to ensure the customer complaint being investigated is appropriately represented

• Collaborate with Device to update the Device Risk Management files, as needed.

• Review and approve reportable external customer complaint investigation reports prior to their submission to health authority

• Assist with maintenance of MDCP data across our company's IT systems, including but not limited to SAP ECC, SAP PLM, and Veeva Quality and Regulatory Vaults

• Coordinates, approves as Quality role all creations and changes to SAP master data field ZZMAT_MDCP_ID

• Submits SAP post-approval updates to GCM TW team to complete the same MDCP identifier updates GCM updates

• Maintains SAP access and role mapping for Device Quality & Regulatory Complaints team

• Supports team as LMS training system steward

• Maintains team SharePoint sites

• Maintains MDCPQ mailbox and associated activities

• Maintains metrics and reporting associated with MDCP deviations, changes, CAPAs and complaints

Education/Experience minimum requirement:

• 1-3 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.

• Required: Bachelor’s degree in Science, Engineering, Health Care, STEM or related technical field

Required Skills:

• Demonstrate the ability to work effectively in teams. Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.

• A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.

• Must work independently and have excellent interpersonal relationship skills with flexibility to adapt to a fast-paced environment with changing priorities. Ability to work in a matrix organization and effective written and oral communicator.

Preferred experience and skills:

• Working knowledge of applicable medical device regulations (21CFR820, EU MDR, ISO 13485:2016), Risk Management Experience (ISO 14971:2012).

• Experience in Complaint Handling investigation process

• Understanding of Combination Product regulations (21 CFR Part 4 including Post Market Safety Reporting requirements).

#EligibleforERP

Required Skills:

Adaptability, Complaints Investigation, Creative Thinking, Cross-Functional Teamwork, Detail-Oriented, Problem Solving, Working Independently

Preferred Skills:

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US and Puerto Rico Residents Only:

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